Record of Proceedings for the Science Advisory Committee on Health Products Containing Cannabis (SAC-HPCC): November 2 & 3, 2020

• Session 1 - November 2, 2020, 3-5pm Eastern time
• Session 2 - November 3, 2020, 3-5pm Eastern time

Session 1 – November 2, 2020, 3-5pm Eastern time

Welcome and opening remarks

The Acting Associate Assistant Deputy Minister of the Health Products and Food Branch welcomed participants to the meeting, thanked members for their commitment and membership, and outlined the goals and plan for the Committee.

Roundtable and introductions

The Committee Co-Chairs led introductions and invited each member to share a few words with the Committee.

Terms of reference and mandate of the Committee

The Executive Secretary of the Committee, the Director General of the Policy Planning and International Affairs Directorate (PPIAD), provided an overview of the terms of reference and mandate of the Committee. This included an overview of member obligations, security requirements and requirements to provide updated declarations and affiliations. Members approved the terms of reference.

Presentations

Overview of the Cannabis Framework

Committee members received a presentation on the current Canadian cannabis framework from the Controlled Substances and Cannabis Branch. This presentation included an overview of the:

• Regulatory and legislative context
• Cannabis Act
• Key elements of the Cannabis Regulations:
  • Cannabis products
  • Promotion, packaging and labelling requirements
  • Drugs containing cannabis
  • The access to cannabis for medical purposes program
  • Post-market monitoring
• International context

Following the presentation, discussion topics included the classification of cannabis products, labelling requirements, and challenges with conducting cannabis research.

Overview of Health Products Containing Cannabis

Members received a presentation on the current framework for health products containing cannabis from PPIAD. This presentation included an overview of:

• The regulatory framework (Food & Drugs Act, Cannabis Act and cannabis exemption regulations)
• The regulatory pathways for cannabis
• The roles and responsibilities for drug scheduling in Canada
• The Summary report: Consultation on potential market for health products containing cannabis that would not require practitioner oversight
• How other jurisdictions are regulating cannabis

Following the presentation committee members discussed evidence requirements to support health claims, health risk and benefit considerations, and long term-safety monitoring.

Closing remarks

The Committee’s Executive Secretary and the Co-Chairs thanked members for their participation and expressed their anticipation for the second part of the meeting, to occur the following afternoon.

Session 2 – November 3rd 2020, 3-5pm Eastern time

Welcome and introductory remarks

The Co-Chair welcomed members, and invited members to provide any new declarations of interest. No updates were declared.

Presentations

The Prescription Drug List (PDL): How Health Canada determines the prescription status of drugs

The Committee received a presentation on the Prescription Drug List (PDL) from the Therapeutic Products Directorate. The presentation included an overview of:

• The regulatory context for the PDL
• Factors considered in PDL decisions
• The removal of a drug from the PDL
• Examples of previous switches to non-prescription/natural health product (NHP) status

Questions and discussion following the presentation focused on the type of post-market information considered in decision-making and the role of pharmacists.

Natural health products and non-prescription drugs

Committee members received a presentation on the current Canadian framework for natural health products and non-prescription drugs from the Natural and Non-prescription Health Products Directorate.

The presentation included an overview of the:

• Regulatory context
• Key components of the Natural Health Products Regulations (types of health claims, evidentiary standards and licensing approach)
• Regulations for non-prescription drugs and their approval process

Topics raised during the subsequent question and answer period included adverse reaction reporting requirements, labeling requirements, types of evidence accepted for various product types, data availability, the differences between compounds found in cannabis and the importance of seeking pharmacist perspectives.

Overview of veterinary drug framework

The Committee members received a presentation on the current Canadian framework for veterinary drugs from the Veterinary Drugs Directorate (VDD). The presentation included an overview of:

• The mandate, authorities and key activities of the VDD
• The regulatory context for veterinary drugs, including prescription and non-prescription products, as well as Veterinary Health Products
• The requirements for safety, efficacy and quality of veterinary drugs
• The current context for veterinary products containing cannabis

Following the presentation, members discussed potential food safety and export implications, off-label drug use and dosing considerations.

Closing remarks

The Executive Secretary of the Committee, the Director General of PPIAD, thanked members for their participation and adjourned the meeting.